Eli Lilly has succeeded in convincing the US International Trade Commission (ITC) to investigate its complaint that Hospira and three suppliers are using a manufacturing process that infringes a patent on its Gemzar cancer med. And Lilly hopes the ITC will block importation of Hospira’s generic version.
In its complaint, Lilly charges that the patented method for making Gemzar “involves less steps, higher yields and lower costs,” according to the Lilly complaint. Hospira and its suppliers are charged with illegally using Lilly’s patented method.
The legal battle over Gemzar is hardly new, having played out in several other countries. A US federal appeals court last November upheld a 2009 decision against Lilly patent claims. After that ruling, Hospira promptly began shipping its generic version. That move contributed to a 22 percent decline in Gemzar sales in the 2010 Qtr4 and an overall 3 percent drop in worldwide Gemzar sales last year of $1.15 billion, which equalled 5 percent of Lilly revenue. Due to Lilly's revenue situation with several key sellers reaching patent expiration, including Gemzar, any loss of revenue is acutely felt.
The use of the ITC route to block its competitors is somewhat novel -- but can only be applied where a generic product is actually produced abroad (outside US) and experts note that the ITC is not noted for its speed with these cases. Thus, it seems unlikley that this will be a general path employed by the pharma industry to block competition.
Posted by Bruce Lehr March 21st 2011.